About the Role

Our client, a dynamic pharmaceutical company focused on developing innovative therapies, is seeking a proactive Regulatory Affairs Specialist to join their team. This role, based in Kimberley, Northern Cape, operates under a hybrid model, combining essential on-site presence with remote work flexibility. You will play a crucial role in ensuring that the company's products comply with all relevant national and international regulatory requirements. This involves preparing and submitting regulatory documentation, liaising with health authorities, and providing regulatory guidance to internal teams. The ideal candidate will possess a solid understanding of regulatory affairs processes within the pharmaceutical industry and a keen eye for detail, ensuring successful product approvals and continued market access. You will be integral to bringing vital medicines to patients, contributing to regulatory strategy from Kimberley.

Key Responsibilities

- Prepare, review, and submit regulatory applications (e.g., CTD dossiers, variations) to health authorities.
- Manage and maintain regulatory filings and ensure compliance with labeling requirements.
- Liaise effectively with regulatory agencies to facilitate timely product approvals and address inquiries.
- Provide regulatory guidance and support to cross-functional teams, including R&D;, clinical, manufacturing, and marketing.
- Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
- Develop and implement regulatory strategies for product development and lifecycle management.




- Review promotional materials to ensure compliance with regulatory advertising and promotion regulations.
- Maintain regulatory databases and documentation systems.
- Participate in regulatory inspections and audits.
- Contribute to the development of departmental SOPs and training materials.

Requirements

- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- A Master's degree or equivalent experience is an advantage.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- Strong knowledge of global regulatory requirements and submission processes (e.g., FDA, EMA, SAHPRA).
- Experience with dossier preparation (e.g., CTD format) and lifecycle management.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Strong analytical, problem-solving, and organizational skills.
- Ability to work independently and collaboratively within a hybrid team environment.
- Proficiency in regulatory information management systems and Microsoft Office Suite.
- Attention to detail and a commitment to compliance and ethical standards.

Benefits

- Competitive salary and performance-based bonus opportunities.
- Comprehensive health, dental, and retirement benefits.
- Generous annual leave allowance and paid holidays.
- Opportunities for professional development and continuing education.
- Hybrid work model promoting work-life balance.
- Supportive team environment and potential for career growth.
- Involvement in impactful projects contributing to healthcare advancements.

📌 Regulatory Affairs Specialist (Kimberley)
🏢 Placements24
📍 Kimberley